Software in Medical Devices, by MD101 Consulting

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Unique Device Identification for software medical device - part 1

Unique Device Identification (UDI) had been in the pipes of regulators for a few years, beginning with the US in 2007, and following (as usual) by the European Union a few years later in 2012.
In parallel, the International Medical Device Regulators Forum (IMDRF) issued in 2011 a guidance on UDI, with the honorable objective of harmonizing UDI's all over the world.
What is the impact of these regulations and guidances on medical device software?

Current Status

While the IMDRF guidance is still public and available, this is not a regulation and doesn't come in force in any country.
In the US, the congress passed a law in 2007, directing the FDA to to develop the regulation. It is still in the process of being adopted. The FDA released a proposal late 2012 and a guidance is planned for the end of this year, according to CDRH.
In Europe, a recommendation was released by the European Commission in april 2013. As such, this is not a regulation and has no legal force in member states of Europe.
Links to documents are given below:

Good news! All these various states and organizations show the political will to build an interoperable UDI system.

What should be a UDI

A UDI is composed of two parts:

  • a Device Identifier (DI),
  • a Production Identifier (PI).

The DI is like the product identifier or brand name or product version. Something that makes the product unique.
The PI is like the lot batch or lot number or product serial number. Something that makes the product items unique.

The UDI shall also have 2 other characteristics to be interoperable:

  • Be automatically readable with scanners of barcodes, QR codes, or similar 1D or 2D encoding,
  • Be transmitted by the mean of HL7 or XML standards, or similar interoperability protocols.

Note: "or similar" because things are still in discussions.

The final purpose of this system is to centralize data in databases owned by regulation authorities. These databases can be used for traceability of products and products recalls.

What is all about for medical device software? We'll see that in the article next week.

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